NEWTOWN, Pa., Sept. 6, 2013 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (Nasdaq:ONTX) a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today provided a corporate update and reported financial results for the second quarter ended June 30, 2013. "Onconova has made significant progress over the past few months," commented Ramesh Kumar, Ph.D., President and CEO of Onconova. "We recently announced complete enrollment of the Phase 3 trial of intravenous (IV) rigosertib in patients with higher risk myelodysplastic syndromes (MDS) and presented data from trials testing oral rigosertib in lower risk MDS and solid tumors. Further, the successful completion of our initial public offering will help continue the advancement of rigosertib, our lead clinical candidate, through upcoming, multiple development milestones." Recent Business Highlights
- Onconova closed its initial public offering of common stock on July 30, 2013, raising net proceeds of $79.6 million.
- In June 2013, Onconova reported interim response and safety data from a trial testing front-line oral rigosertib in transfusion-dependent, lower risk MDS patients.
- In May 2013, Onconova announced reaching its enrollment goal for the Phase 3 trial of IV rigosertib in patients with higher risk MDS.
- In May 2013, Onconova initiated a multi-center Phase 2 trial with oral rigosertib in transfusion-dependent, lower risk MDS patients who have failed treatment with erythropoiesis-stimulating agents.
- In April 2013, Onconova announced results from a Phase 1 trial of oral rigosertib in patients with various advanced solid tumors refractory to standard therapy, including patients with head and neck cancers who had previously failed platinum-based therapy. Based on these results we initiated a Phase 2 trial in relapsed or metastatic head and neck cancers.
- Total net revenue for the second quarter of 2013 was $0.6 million and $1.7 million for the six months ended June 30, 2013, compared to $0.2 million and $0.4 million for the comparable periods in 2012. The increase resulted from recognition of collaboration revenue from our license and development agreement for rigosertib with Baxter International, Inc.
- Research and development expenses were $10 million for the second quarter of 2013 and $22.8 million for the six months ended June 30, 2013, compared to $6.8 million and $15.2 million for the comparable periods in 2012. The increase was largely driven by added costs related to clinical studies of rigosertib.
- General and administrative expenses were $3.1 million for the second quarter of 2013 and $6.5 million for the six months ended June 30, 2013, compared to $1.6 million and $4.1 million for the comparable periods in 2012. The increase was largely driven by incremental expenses to support our anticipated public company operations as well as increased stock-based compensation expense and other costs to support the Company's growth.
- Net loss was $12.6 million for the second quarter of 2013 and $27.4 million for the six months ended June 30, 2013, compared to $7.4 million and $18.2 million for the comparable periods in 2012.
- Cash and cash equivalents as of June 30, 2013 totaled $51.2 million (which does not include the $79.6 million in net proceeds from the Company's initial public offering) compared to $81.5 million at December 31, 2012.
- Presentation of overall results from the Phase 2 trial of oral rigosertib in transfusion-dependent, lower risk MDS at the American Society of Hematology, or ASH, Annual Meeting in December 2013.
- Interim analysis of 150 patients in the Phase 3 trial of IV rigosertib plus gemcitabine in metastatic pancreatic cancer in either the fourth quarter of 2013 or the first quarter of 2014.
- Top-line survival results from the Phase 3 trial of IV rigosertib in higher risk MDS in either the fourth quarter of 2013 or the first quarter of 2014.
Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
|ONCONOVA THERAPEUTICS, INC.|
|June 30,||December 31,|
|Cash and cash equivalents||$ 51,181||$ 81,527|
|Prepaid expenses and other current assets||5,867||1,725|
|Total current assets||57,048||83,252|
|Property and equipment, net||729||463|
|Other non-current assets||137||137|
|Total assets||$ 57,914||$ 83,852|
|Liabilities, redeemable convertible preferred stock and stockholders' deficit|
|Accounts payable||$ 4,410||$ 5,517|
|Accrued expenses and other current liabilities||5,388||3,987|
|Total current liabilities||13,307||25,378|
|Deferred revenue, non-current||14,136||15,421|
|Redeemable convertible preferred stock||203,366||201,315|
|Additional paid in capital||22,787||10,021|
|Accumulated other comprehensive income||5||--|
|Total stockholders' deficit||(172,942)||(158,306)|
|Total liabilities, redeemable convertible preferred stock and stockholders' deficit||$ 57,914||$ 83,852|
|ONCONOVA THERAPEUTICS, INC.|
|Condensed Consolidated Statements of Operations (unaudited)|
|(in thousands, except per share amounts)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Revenue||$ 591||$ 220||$ 1,707||$ 418|
|General and administrative||3,117||1,627||6,463||4,087|
|Research and development||10,047||6,776||22,803||15,224|
|Total operating expenses||13,164||8,403||29,266||19,311|
|Loss from operations||(12,573)||(8,183)||(27,559)||(18,893)|
|Change in fair value of warrant liability||(2)||999||12||390|
|Other income (expense), net||15||(2)||142||539|
|Accretion of redeemable convertible preferred stock||(1,032)||(927)||(2,051)||(2,158)|
|Net loss applicable to common stockholders||$ (13,594)||$ (8,343)||$ (29,458)||$ (20,373)|
|Net loss per share of common stock, basic and diluted||$ (5.21)||$ (3.84)||$ (11.29)||$ (9.37)|
|Basic and diluted weighted average shares outstanding||2,609,495||2,173,549||2,608,450||2,173,549|
CONTACT: Onconova Therapeutics Benjamin Hoffman, 267-759-3680 email@example.com or Media: MacDougall Biomedical Communications Chris Erdman, 781-235-3060 firstname.lastname@example.org